BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE PASSIVE X-SERIES NEEDLE GUARD SYRINGE

    MDR report key: 9245236 · Received October 28, 2019

    Report

    Report Number
    3009081593-2019-00237
    Event Type
    Malfunction
    Date Received
    October 28, 2019
    Date of Event
    September 5, 2019
    Report Date
    October 30, 2019
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NEITHER SAMPLE NOR PHOTO WAS PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BDM-PS PERFORMED A BATCH HISTORY RECORD¿S REVIEW (BHR) INCLUDING A REVIEW OF ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCHES INVOLVED IN THIS COMPLAINT MEET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. BASED ON INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY CUSTOMER OR CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE IS DIFFICULT TO OPERATE. THIS OCCURRED ON 2 OCCASIONS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SITE ALSO PROVIDED PICTURES WHERE THE PULLED IN NEEDLE IS VISIBLE AND WHERE YOU CAN SEE THAT SOME LIQUID IS STILL INSIDE. THE SITE MENTIONED THAT THEY DEFINITELY DON´T THINK THE PATIENT HANDLED SOMETHING WRONG.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7033272, MEDICAL DEVICE EXPIRATION DATE: 2022-01-31, DEVICE MANUFACTURE DATE: 2017-02-02. MEDICAL DEVICE LOT #: 7114347, MEDICAL DEVICE EXPIRATION DATE: 2022-03-31, DEVICE MANUFACTURE DATE: 2017-04-24. PMA/510(K)#: K011369, K122558. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRASAFE PASSIVE" X-SERIES NEEDLE GUARD SYRINGE IS DIFFICULT TO OPERATE. THIS OCCURRED ON 2 OCCASIONS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SITE ALSO PROVIDED PICTURES WHERE THE PULLED IN NEEDLE IS VISIBLE AND WHERE YOU CAN SEE THAT SOME LIQUID IS STILL INSIDE. THE SITE MENTIONED THAT THEY DEFINITELY DON'T THINK THE PATIENT HANDLED SOMETHING WRONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042716 BD ULTRASAFE PASSIVE X-SERIES NEEDLE GUARD SYRINGE PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other